Safety Recalls

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15,364 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

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Showing 9,901–9,950 of 15,364

Food Recall · October 2, 2024
DYMA BRANDS
Sysco Classic Fruit Punch Drink Mix Natural and Artificial Flavor, NET WT. 8.6OZ (244 G), Case UPC 00734730132709, DISTRIBUTED BY SYSCO CORPORATION, HOUSTON, TEXAS 77077
After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
Class II
Food Recall · October 2, 2024
DYMA BRANDS
MONARCH INSTANT CHOCOLATE PUDDING & PIE FILLING MIX NATURALLY AND ARTIFICIALLY FLAVORED, NET WT. 24OZ, Case UPC 50758108068983 DISTRIBUTED BY US FOODSS, INC ROSEMONT, IL 60018
After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
Class II
Food Recall · October 2, 2024
DYMA BRANDS
CULINARY SECREST ORIGINALS VANILLA INSTANT PUDDING MIX NATURAL & ARTIFICIAL FLAVOR, NET WT. 24 OZ. (1.5 LB.) 680g, 8 UPC 22486 19071 2, Case UPC 30822486190706 and NET WT. 28 OZ. (1.75 LB.) 793g, UPC
After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
Class II
Food Recall · October 2, 2024
DYMA BRANDS
Katy's KITCHEN Originals LEMON GELATIN MIX MEXCLA DE GELATINA DE LIMON, NET WT. 24 OZ. (1.5 LBS.) 680 g, UPC 8 22486 11794 8, Case UPC 30822486117918; Katy's KITCHEN Originals LIME GELATIN MIX, NET WT
After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
Class II
Food Recall · October 2, 2024
DYMA BRANDS
Sysco Classic Lemonade Drink Mix Natural Flavor, NET WT. 24OZ (1 LB 8 OZ) 690g, UPC 0 74865 09325 5, Case UPC 10074865093252, DISTRIBUTED BY SYSCO CORPORATION, HOUSTON, TEXAS 77077ON, HOUSTON, TEXAS 7
After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
Class II
Food Recall · October 2, 2024
DYMA BRANDS
REJUV ORIGINALS LOW CALORIE ORANGE DRINK MIX NATURAL FLAVOR, NET WT. 8.6 OZ. (244g), UPC 8 22486 14388 6, Case UPC 30822486143887, MARKETED BY INDEPENDENT MARKETING ALLIANCE HOUSTON, TX 77043
After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
Class II
Food Recall · October 2, 2024
DYMA BRANDS
Sysco Classic Banana Instant Pudding & Pie Filling Mix Natural and Artificial Flavor, NET WT. 24 OZ (1 LB 8 OZ) 680g, UPC 0 74865 11559 9, Case UPC 10074865115596, DISTRIBUTED BY SYSCO CORPORATION, HO
After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
Class II
Food Recall · October 2, 2024
DYMA BRANDS
Sysco Classic Vanilla Instant Pudding & Pie Filling Mix Natural and Artificial Flavor, NET WT. 32 OZ (2 LB) 907g, UPC 0 74865 20116 2, Case UPC 10074865201169, DISTRIBUTED BY SYSCO CORPORATION, HOUSTO
After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
Class II
Food Recall · October 2, 2024
DYMA BRANDS
REJUV ORIGINALS PINK LEMONADE DRINK MIX NATURAL FLAVOR, NET WT. 24OZ. (680g), UPC 8 22486 11808 2, Case UPC 30822486118083, MARKETED BY INDEPENDENT MARKETING ALLIANCE HOUSTON, TX 77043
After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
Class II
Food Recall · October 2, 2024
DYMA BRANDS
SYSCO PINK LEMONADE, NET WT. 24OZ, UPC 0 74865 09326 2, Case UPC 10074865093269, DISTRIBUTED BY SYSCO CORPORATION, HOUSTON, TEXAS 77077
After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
Class II
Food Recall · October 2, 2024
DYMA BRANDS
Gordon CHOICE Lemonade Beverage Mix Naturally Flavored Low Calorie Instant LOW CAL LEMONADE, NET WT. 8.6 OZ (243 g), UPC 0 93901 59605 5, Case UPC 10093901596052, FOR DISTRIBUTION EXCLUSIVELY BY PARA
After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
Class II
Food Recall · October 2, 2024
DYMA BRANDS
SYSCO VANILLA INSTANT, NET WT. 24OZ, Case UPC 10074865103791, DISTRIBUTED BY SYSCO CORPORATION, HOUSTON, TEXAS 77077
After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
Class II
Food Recall · October 2, 2024
DYMA BRANDS
THIRSTER Lemonade Drink Mix NATURALLY FLAVORED LOW CALORIE, NET WT. 8.6 OZ (244 g), UPC 7 58108 39736 4, Case UPC 50758108397359, DISTRIBUTED BY US FOODS, INC. ROSEMONT, IL 60018
After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
Class II
Food Recall · October 2, 2024
DYMA BRANDS
AROMA VITA HOT COCOA MIX, NET WT. 32OZ (2LBS) 907g, UPC 7 1908 50007 0, Case UPC 50719098500075, Distributed by DYMA Brands, Inc. Atlanta, GA 30328
After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
Class II
Food Recall · October 2, 2024
DYMA BRANDS
SYSCO LOW CAL LEMONADE, NET WT. 8.6OZ, Case UPC 00734730132648, DISTRIBUTED BY SYSCO CORPORATION, HOUSTON, TEXAS 77077
After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
Class II
Food Recall · October 2, 2024
DYMA BRANDS
SYSCO FRUIT PUNCH, NET WT. 24OZ, Case UPC 10074865093221, DISTRIBUTED BY SYSCO CORPORATION, HOUSTON, TEXAS 77077
After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
Class II
Food Recall · October 2, 2024
DYMA BRANDS
Sysco Classic Pink Lemonade Drink Mix Natural Flavor, NET WT. 24OZ(1 LB 8 OZ) 680 g, UPC 0 74865 09326 2, Case UPC 10074865093269, DISTRIBUTED BY SYSCO CORPORATION, HOUSTON, TEXAS 77077
After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
Class II
Food Recall · October 2, 2024
DYMA BRANDS
THIRSTER LOW CAL FRUIT, NET WT. 8.6OZ, Case UPC 50758108397380, DISTRIBUTED BY US FOODS, INC. ROSEMONT, IL 60018
After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
Class II
Medical Device Recall · October 2, 2024
Smith & Nephew Medical, Ltd.
RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and bo
Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.
Class II
Medical Device Recall · October 2, 2024
Limacorporate S.p.A
TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total elbow prosthesis.
Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.
Class II
Medical Device Recall · October 2, 2024
Smith & Nephew Inc
smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275; Uncoated knee femur prosthesis, metallic
Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.
Class II
Medical Device Recall · October 2, 2024
Smith & Nephew Inc
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.
Class II
Medical Device Recall · October 2, 2024
Smith & Nephew Inc
smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic
Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.
Class II
Medical Device Recall · October 1, 2024
Abbott Medical
Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted heart device to Merlin.net" Patient Care Network (PCN) to fa
Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.
Class III
Medical Device Recall · October 1, 2024
Advanced Medical Solutions Ltd.
McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to control minor bleeding in superficial wounds.
Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
Class II
Food Recall · October 1, 2024
Jack & The Green Sprouts, Inc.
Jack & the Green Sprouts Alfalfa, Net Weight 5 oz (142g). UPC 7 63247-19891 5 Keep Refrigerated. Product of USA. Jackandthegreensprouts.com, River Falls, WI 54022. EXPANDED 10/4/2024: Produc
Sprouts may be contaminated with Listeria monocytogenes.
Class I
Medical Device Recall · October 1, 2024
Advanced Medical Solutions Ltd.
MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB EXTRA ALBINATE WOUND DRESSING 4X8 RECTANLE REF MSC7048EP Wound dressing indicated for moderate to heavily exudi
Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
Class II
Vehicle Recall · October 1, 2024
Lucid USA, Inc.
2023 LUCID AIR
A high voltage coolant heater that fails to defrost the windshield can reduce the driver's view, increasing the risk of a crash.
Unclassified
Food Recall · October 1, 2024
Jack & The Green Sprouts, Inc.
Jack & the Green Sprouts Alfalfa & Onion, Net Weight 5 oz (142g). UPC 7 63247-19594 5 Keep Refrigerated. Product of USA. Jackandthegreensprouts.com, River Falls, WI 54022
Sprouts may be contaminated with Listeria monocytogenes.
Class I
Medical Device Recall · October 1, 2024
Abbott Medical
Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capability is a transmitter configured for multiple patient use. It can receive inf
Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.
Class III
Vehicle Recall · October 1, 2024
Volvo Car USA, LLC
2024 VOLVO XC40
A nonfunctioning exterior turn signal may not notify other drivers of a turning vehicle, increasing the risk of a crash.
Unclassified
Drug Recall · October 1, 2024
ACCORD HEALTHCARE, INC.
Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Accord Healthcare Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals L
Failed Impurities/Degradation Specifications.
Class II
Medical Device Recall · October 1, 2024
Advanced Medical Solutions Ltd.
Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for moderate to heavily exuding chronic and acute wounds such as: ¿ pressure ulcers ¿ leg ulcers
Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
Class II
Medical Device Recall · September 30, 2024
NuVasive Specialized Orthopedics, Inc.
Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 280mm PM10.0-80B305 PRECI
Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices.
Class II
Drug Recall · September 30, 2024
Glenmark Pharmaceuticals Inc., USA
Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only, a) 30 gm Tube, NDC 68462-0455-35; b) 45 gm Tube, NDC 68462-0455-47; c) 100 gm Tube, NDC 68462-0455-94, Manufactured by: G
Defective Container: Firm received complaints of broken tube at the seal.
Class III
Food Recall · September 30, 2024
Yucatan Products dba Lorena Sandoval
El Gallo Azul Cock Brand Queso Procesado/Processed Cheese 300g packaged in a metal can
Non-English labeling
Class II
Medical Device Recall · September 30, 2024
Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
The IMMULITE 2000 PSA assay for use on the IMMULITE 2000 and IMMULITE 2000 XPi analyzers did not meet the High-dose Hook Effect claim as stated in the Instructions for Use (IFU).
Class II
Medical Device Recall · September 30, 2024
Beckman Coulter, Inc.
The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Ac
The Access Cortisol assay protocol file (APF) applies an incorrect calibration curve acceptance parameter at the S1 calibrator level that can lead to a high rate of calibration failures which can vary by reagent lot number. Calibration failure would lead to delay of measurement results reporting and potential injuries.
Class II
Food Recall · September 30, 2024
Puget Consumers Co-Op
Hungarian Mushroom Soup sold at PCC Community Market as: (1) Sold in grab and go plastic retail container, net wt. 24 oz. UPC 20452200000. (2) Sold hot in self-serve soup bar. (3) Sometimes used as a
Product is recalled due to possible presence of larvae.
Class II
Drug Recall · September 30, 2024
Staska Pharmaceuticals, Inc.
Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, Rx only, Staska Pharmaceuticals, 742 Evergreen Drive, Bennet, NE 68317
Presence of Particulate Matter: Presence of glass particulates.
Class I
Medical Device Recall · September 30, 2024
Zyno Medical LLC
Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood p
For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been loaded in accordance with ongoing correction Z-1183-2024.
Class III
Medical Device Recall · September 30, 2024
Bard Peripheral Vascular Inc
Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210; BARD MARQUEE 12G X 10 CM, REF: MQ1210; BARD MARQUEE Kit 12G X 13 CM, REF: MQK1213; BARD MARQUEE 12G
Disposable biopsy instruments were potentially manufactured missing the backend notch retention feature on the needle that results in inadequate securing of the needle inside the device, which could lead to needle detachment and misplacement, which could lead to tissue damage and bleeding.
Class II
Food Recall · September 29, 2024
Westby Cooperative Creamery
Westby Pepper Cheese Curds, 12 oz. (340g) UPC 7 50388-30105 2. Keep Refrigerated. No Added Preservatives. Manufactured by Westby Cooperative Creamery, Westby, WI 54667.
Cheese curds may be contaminated with generic E. coli.
Class II
Food Recall · September 29, 2024
Westby Cooperative Creamery
Westby Cheese Curds, UPC 7 50388-30105 2. Keep Refrigerated. No Added Preservatives. Manufactured by Westby Cooperative Creamery, Westby, WI 54667. White, Yellow, and Mixed Curds are packaged in
Cheese curds may be contaminated with generic E. coli.
Class II
Food Recall · September 28, 2024
Pacific Coast Fresh CO
King Harvest Spinach Hummus, perishable and refrigerated, packed in plastic tubs with tamper evident lids. Net wt. 10oz. Dist. Exclusively by Pacific Coast Fresh Co Portland, Oregon. UPC 0 25726 31108
Recall initiated due to potential plastic fragments.
Class II
Medical Device Recall · September 27, 2024
Westmed, Inc.
1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF S6411P 2) Flex Extender, 5.2" x 15mm OD x 22/15mm ID REF 7 5132 The Westmed Flex Extenders are non invasive, single use/disposable, large bore, co
Due to connector within the circuit flex extender not meeting specifications resulting in a low connection force and as a result, the connector may leak or disconnect and may cause life threating conditions or death.
Class II
Food Recall · September 27, 2024
Lund Food Holdings Inc
Lunds & Byerlys lone star dip. Net Wt 12 oz. (340.5g) UPC 0 18169-74197 9. Produced by Lunds & Byerlys, Edina, MN 55424.
Potential mold contamination.
Class II
Medical Device Recall · September 27, 2024
Accriva Diagnostics, Inc.
AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may result in incorrect patient results where oxygen levels are higher than actual results, which may lead to patient care mismanagement requiring medical intervention.
Class II
Food Recall · September 26, 2024
Walmart Inc
Great Value Cherry Mixed Fruit, 4 oz, 4 Count and 12 count plastic cups sealed with clear film.
FD&C Red No 3 was not declared as an ingredient.
Class III
Medical Device Recall · September 26, 2024
King Systems Corp. dba Ambu, Inc.
KING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD4225
Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
Class II